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Weekly Drug News Round-Up: April 24, 2019
Posted yesterday in Pharmaceutical News
AbbVie’s IL-23 Inhibitor Skyrizi Approved for Plaque Psoriasis In the U.S., psoriasis is a common autoimmune disease and affects roughly 7.5 million Americans Read More... The U.S. Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) from AbbVie. Skyrizi is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis in adults who are candidates for systemic therapy or... Read more
Health Highlights: April 24, 2019
Posted yesterday in Medical
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: U.S. Air Pollution Worsening Under Trump: Report Air pollution in the United States has worsened during the Trump administration, the American Lung Association's annual State of the Air report says. More than 141 million Americans -- 4 in 10 -- live in counties with air that has unhealthy levels of particle... Read more
1998 to 2015 Saw Increase in Outpatient Depression Treatment
Posted today in News for Health Professionals
WEDNESDAY, April 24, 2019 -- From 1998 to 2015, there was an increase in outpatient treatment of depression, according to a study published online April 24 in JAMA Psychiatry. Jason M. Hockenberry, Ph.D., from Emory University in Atlanta, and colleagues examined national trends in outpatient depression treatment from 1998 to 2015. Data were assessed from the 1998, 2007, and 2015 Medical Expenditure Panel Surveys,... Read more
Nusinersen Promising for Later-Onset Spinal Muscular Atrophy
Posted today in News for Health Professionals
WEDNESDAY, April 24, 2019 -- Limited evidence suggests that nusinersen treatment provides long-term benefits for children with later-onset spinal muscular atrophy (SMA), according to a study published online April 24 in Neurology. Basil T. Darras, M.D., from Boston Children's Hospital, and colleagues reported results of intrathecal nusinersen in 28 children with later-onset SMA (11 SMA type II; 17 SMA type III).... Read more
New York City Measles Cases Increase to 390
Posted today in News for Health Professionals
WEDNESDAY, April 24, 2019 -- The number of measles cases in New York City has risen to 390, the health department said Wednesday. Of those cases, 323 (83 percent) have been in Williamsburg (ZIP codes 11205, 11206, 11211, 11249), where an emergency order for people to be vaccinated against measles has been in place since April 12. Since the city last week began issuing summonses for not complying with the order, 12... Read more
Many Seniors Will Be Unable to Afford Care They Need by 2029
Posted today in News for Health Professionals
WEDNESDAY, April 24, 2019 -- The number of middle-income seniors is projected to almost double by 2029, and many will have inadequate financial resources to afford the level of care they need, according to a report published online April 24 in Health Affairs. Caroline F. Pearson, from the University of Chicago, and colleagues projected housing needs for middle-income seniors, aged 75 years and older, using data from... Read more
CDC Provides Clarification of Opioid Prescribing Guideline
Posted today in News for Health Professionals
WEDNESDAY, April 24, 2019 -- Implementation of the U.S. Centers for Disease Control and Prevention opioid prescribing recommendations should be consistent with the guideline's intent, according to a perspective piece published online April 24 in the New England Journal of Medicine. Noting that some policies and practices purportedly derived from the 2016 Guideline for Prescribing Opioids for Chronic Pain have been... Read more
Wellness Programs Take Hold in American Workplaces
Posted today in Medical
WEDNESDAY, April 24, 2019 -- Nearly half of U.S. workplaces now offer wellness programs, a new study finds. "Most American adults work, and many spend half or more of their waking hours at work," said study author Laura Linnan. She's a professor in the department of health behavior at the University of North Carolina's School of Global Public Health. "Where we work, how long we work, the conditions of our work,... Read more
Young Adults With Autism Need Jobs, But Resources Vary By State
Posted today in Medical
WEDNESDAY, April 24, 2019 -- There's a lot of news about the dramatic rise in the number of children with autism and the services available to them, but less attention has been paid to what happens when those kids grow up. Now, a new study suggests that finding a job can be a struggle, and just how much of a struggle it is can vary widely from state to state. For example, the difference between neighboring states... Read more
E. Coli Outbreak Tied to Ground Beef Expands to 10 States
Posted today in Medical
WEDNESDAY, April 24, 2019 -- Federal health officials say 156 cases of E. coli illness linked with tainted ground beef have now been spotted across 10 states. That's up from the 109 cases reported from six states just two weeks ago, the U.S. Centers for Disease Control and Prevention reported Tuesday. "Ill people in this outbreak report eating ground beef at home and in restaurants," the CDC said. However, "at... Read more
Could Common Food Preservative Make People Fat?
Posted today in Medical
WEDNESDAY, April 24, 2019 -- If you're watching your weight, you probably know to avoid sugary and fatty foods. But what about preservatives? Eating a preservative widely used in breads, baked goods and cheese may trigger metabolic responses that are linked to obesity and diabetes, an early study suggests. The additive, called propionate, is actually a naturally occurring fatty acid produced in the gut. When it's... Read more
FDA Approves Skyrizi (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis
Posted 2 days ago in New Drug Approvals
NORTH CHICAGO, Ill., April 23, 2019 /PRNewswire/ -- AbbVie today announced that the U.S. Food and Drug Administration (FDA) approved Skyrizi (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.3 In clinical trials, Skyrizi produced high rates of durable skin clearance – most people... Read more
FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC
Posted 8 days ago in New Drug Approvals
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive... Read more
Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
Posted 10 days ago in New Drug Applications
Basel, April 15, 2019 - Novartis announced that the US Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. Seeking to make brolucizumab available as quickly as possible, Novartis used a priority review voucher to expedite FDA review. If... Read more
FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer
Posted 12 days ago in New Drug Approvals
April 12, 2019 -- The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be selected for therapy with Balversa using... Read more
FDA Approves Evenity (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk of Fracture
Posted 2 weeks ago in New Drug Approvals
April 9, 2019 -- The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies. More than 10 million people in the U.S. have osteoporosis,... Read more
Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA
Posted 2 weeks ago in New Drug Applications
Dublin – April 9, 2019 – Cosmo Pharmaceuticals NV (SIX: COPN) today informed that the Remimazolam NDA has been submitted to FDA. Electronic acknowledgment of the submission shows April 5 as the official date of submission. Therefore within 60 days, by June 4, FDA will communicate whether the NDA has been filed for review to proceed. “We are very happy to have been able to submit the NDA of... Read more
FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection
Posted 2 weeks ago in New Drug Approvals
LONDON--(BUSINESS WIRE) April 08, 2019 --ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC. Dovato, a two-drug regimen (2DR),... Read more
Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application
Posted 2 weeks ago in New Drug Applications
EMERYVILLE, Calif., April 08, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Fintepla (ZX008, fenfluramine hydrochloride) for the treatment of seizures associated with Dravet... Read more
Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA
Posted 2 weeks ago in New Drug Applications
SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE) April 05, 2019 -- Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that Celgene has submitted a Biologics License Application (BLA) for luspatercept, an erythroid maturation agent, for the treatment of adult patients with very low to intermediate risk myelodysplastic syndromes (MDS)-associated anemia who have ring... Read more
Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US
Posted 3 weeks ago in New Drug Applications
TOKYO--(BUSINESS WIRE)--Apr 4, 2019--Kyowa Hakko Kirin Co., Ltd. (TOKYO:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for istradefylline (KW-6002), an investigational selective adenosine A 2A receptor antagonist, for use as adjunctive treatment to levodopa/carbidopa in... Read more
Pfizer and Lilly Announce Top-Line Results From Long-Term Phase 3 Study of Tanezumab in Patients With Osteoarthritis
Posted 6 days ago in Clinical Trials
NEW YORK & INDIANAPOLIS--(BUSINESS WIRE) April 18, 2019 -- Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced top-line results from a Phase 3 study evaluating tanezumab 2.5 mg and 5 mg. The objective of the study was to compare the long-term joint safety and 16-week efficacy of tanezumab relative to nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe... Read more
AveXis Data Reinforce Effectiveness of Zolgensma in Treating Spinal Muscular Atrophy (SMA) Type 1
Posted 9 days ago in Clinical Trials
Basel, April 16, 2019 - AveXis, a Novartis company, today announced that interim data from its Phase 3 STR1VE trial of Zolgensma® (onasemnogene abeparvovec-xioi; AVXS-101)[1] in spinal muscular atrophy (SMA) Type 1 showed prolonged event-free survival, an early and rapid increase in CHOP-INTEND scores and significant milestone achievement compared to untreated natural history, consistent with data from the... Read more
MediciNova Announces Plans to Move Forward with a Phase 3 Trial of MN-166 (ibudilast) in ALS
Posted 9 days ago in Clinical Trials
LA JOLLA, Calif., April 15, 2019 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the protocol and determined that MediciNova may proceed with a Phase 2b/3 clinical trial of MN-166... Read more
TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Marginal Zone Lymphoma
Posted 9 days ago in Clinical Trials
NEW YORK, April 15, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to its phosphoinositide-3-kinase (PI3K) delta inhibitor, umbralisib (TGR-1202), for the treatment of patients with all three types of marginal zone lymphoma (MZL): nodal, extranodal, and splenic MZL. Umbralisib monotherapy is being... Read more
Pfizer Announces Presentation of Data from a Phase 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
Posted 12 days ago in Clinical Trials
April 13, 2019 - Pfizer Inc. (NYSE: PFE) announced today the presentation of data from a Phase 2 study of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes contained in the vaccine in adults aged 18 years and older. The presentation was delivered at the 29th European... Read more
